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Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID06754228

Study of Immune Effects from Different Doses of Probiotic Bacillus Coagulans JBI-YZ6.3 BC4U in Healthy Adults

Led by Natural Immune Systems Inc · Updated on 2024-12-31

24

Participants Needed

1

Research Sites

15 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the immediate effects of three different doses of a probiotic strain called Bacillus coagulans JBI-YZ6.3 BC4U on immune function compared to a placebo. This clinical proof-of-concept study involves 24 healthy adult participants aged 18 to 75 years. The goal is to understand how the probiotic influences immune status and cytokine levels shortly after intake. Participants will take placebo and three escalating doses of the probiotic 0 mg placebo, 100 mg, 200 mg, and 400 mg each during separate clinic visits spaced at least one week apart for washout. At each visit, blood samples will be collected before the dose and again at 1, 2, and 3 hours after taking the probiotic or placebo. During the study, participants will undergo blood draws to assess immune communication, immune surveillance, cell activation, cell priming, and cytokine profiles. Researchers will monitor these immune responses up to 3 hours after dosing. The study requires participants to maintain consistent diet and lifestyle habits and involves multiple visits over the course of the trial ending in December 2025.

CONDITIONS

Brief Title

Acute Immune Modulation by Probiotic Strain

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